Galderma Initiates Two New Clinical Trials Investigating Nemolizumab in Patients With Systemic Sclerosis and Chronic Pruritus of Unknown Origin
ZUG, Switzerland--(BUSINESS WIRE)--Jun 25, 2025--
Galderma (SIX: GALD), the pure-play dermatology category leader, today announced the initiation of two new clinical trials to investigate the efficacy and safety of nemolizumab in treating patients living with Systemic Sclerosis (SSc) and Chronic Pruritus of Unknown Origin (CPUO) – two chronic conditions with high unmet need. 1-3,7
Nemolizumab is a monoclonal antibody that specifically targets the IL-31 receptor alpha, inhibiting the signaling of IL-31, a neuroimmune cytokine that plays a role in driving itch – the main symptom of CPUO – and inflammation and fibrosis, which are hallmarks of SSc. 1,3,4
'Investigating nemolizumab in two new trials in Systemic Sclerosis and Chronic Pruritus of Unknown Origin, both of which are associated with poor patient outcomes and low quality of life, underscores our commitment to addressing skin conditions with high unmet needs. These trials may help us better understand these complex diseases and offer hope for patients seeking relief from these severe and potentially life-threatening conditions.'
BALDO SCASSELLATI SFORZOLINI, M.D., PH.D.
GLOBAL HEAD OF R&D
GALDERMA
Systemic Sclerosis (SSc)
SSc is a rare, potentially fatal autoimmune disease that causes inflammation and fibrosis (hardening) of the skin and internal organs. 1 It most commonly affects women between the ages of 30 and 50 years old, often leading to a lower quality of life and a much higher risk of death compared to healthy people of the same age. 2,8 Currently, there are no approved therapies that address the disease as a whole, highlighting the urgent need for effective treatments. 1,2,8
Galderma's phase II proof-of-concept study is a multicenter, randomized, double-blind, placebo-controlled study investigating the pharmacokinetics and pharmacodynamics of nemolizumab in adults with SSc. Patient enrollment is planned to begin in H2 2025, with completion anticipated in 2028. This trial represents a significant step towards addressing the remaining unmet treatment needs in SSc and demonstrates Galderma's commitment to driving progress for patients living with this disease.
The study was designed in collaboration with a Steering Committee of world-leading rheumatology and dermatology experts, including lead trial investigator, Professor Oliver Distler, M.D., Zürich, Switzerland; Professor Dinesh Khanna, M.D., Director of the Scleroderma Program, University of Michigan, United States (U.S.); Professor Robert Spiera, M.D., Director of the Scleroderma, Vasculitis and Myositis Center, Hospital for Special Surgery, New York, U.S.; and Professor Johann Gudjonsson, M.D., PhD, Dermatologist, University Hospital Michigan, U.S.
The trial is expected to be conducted in several countries in North America, Europe and South America. More information about the study will be made available soon on the clinicaltrials.gov website.
'Systemic Sclerosis can have a profound impact on both the quality and length of a person's life. It causes the skin to harden, damages blood vessels, leads to joint pain, and can result in serious fibrosis in multiple internal organs, sometimes with life-threatening consequences. With no currently approved treatments that are indicated to treat the several symptoms this autoimmune disease presents, I look forward to investigating the role that nemolizumab could potentially play in this condition.'
PROFESSOR OLIVER DISTLER, M.D.
LEAD INVESTIGATOR: SYSTEMIC SCLEROSIS PHASE II STUDY
ZÜRICH, SWITZERLAND
Chronic Pruritus of Unknown Origin (CPUO)
CPUO is an underdiagnosed condition defined as itch lasting for more than six weeks without an identified cause and mostly affects the elderly. 3 The chronic and persistent itch is often described as being as debilitating as chronic pain, leading to reduced quality of life and affecting sleep patterns and mood. 3,7 There are currently no approved treatments for this condition. 3
Galderma's new phase II CPUO trial reinforces the company's commitment to exploring options for patients with chronic skin conditions that significantly impact quality of life. This randomized, double-blind, placebo-controlled proof-of-concept study will explore the pharmacokinetics and pharmacodynamics of nemolizumab in adults. Enrollment is expected to start in H2 2025 in the U.S., with completion anticipated in 2026. The study was designed in collaboration with a Steering Committee of world-leading dermatology experts, including the lead investigator Dr. Shawn Kwatra, M.D., PhD., Joseph W. Burnett Endowed Professor, Chairman of Dermatology, University of Maryland School of Medicine, U.S., and Dr. Sarina Elmariah, MD, PhD, MPH, Associate Professor and Dermatology Director at the Center for Itch and Neurosensory Disorders at the University of California in San Francisco, U.S.
The study is being conducted in the U.S. and more information about the study will be made available soon on the clinicaltrials.gov website.
'It is challenging to treat Chronic Pruritus of Unknown Origin as physicians have limited therapeutic options specifically targeting the underlying cause of itch. With the extensive data showing that IL-31 is a key driver of itch, I'm excited to explore whether nemolizumab's inhibition of IL-31 signaling might effectively reduce the intractable itch experienced by patients with Chronic Pruritus of Unknown Origin.'
DOCTOR SHAWN KWATRA, M.D., PHD
LEAD INVESTIGATOR, CHRONIC PRURITUS OF UNKNOWN ORIGIN PHASE II STUDY
JOSEPH W. BURNETT ENDOWED PROFESSOR
CHAIRMAN OF DERMATOLOGY, UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE, U.S.
About nemolizumab
Nemolizumab was approved in August 2024 by the U.S. Food and Drug Administration (U.S. FDA) for the treatment of adults with prurigo nodularis. 5 In December 2024, it was also approved by the U.S. FDA for the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis, in combination with topical corticosteroids and/or calcineurin inhibitors when the disease is not adequately controlled with topical prescription therapies. 5 To date, nemolizumab is approved for both moderate-to-severe atopic dermatitis and prurigo nodularis by multiple regulatory authorities around the world, including in the European Union, Australia, Singapore, Switzerland and the United Kingdom. Additional regulatory submissions and reviews are ongoing.
Nemolizumab was initially developed by Chugai Pharmaceutical Co., Ltd. In 2016, Galderma obtained exclusive rights to the development and marketing of nemolizumab worldwide, except in Japan. In Japan, nemolizumab is marketed as Mitchga ® and is approved for the treatment of prurigo nodularis, as well as pruritus associated with atopic dermatitis in pediatric, adolescent, and adult patients. 9,10
About Galderma
Galderma (SIX: GALD) is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that span the full spectrum of the fast-growing dermatology market through Injectable Aesthetics, Dermatological Skincare and Therapeutic Dermatology. Since our foundation in 1981, we have dedicated our focus and passion to the human body's largest organ – the skin – meeting individual consumer and patient needs with superior outcomes in partnership with healthcare professionals. Because we understand that the skin we are in shapes our lives, we are advancing dermatology for every skin story. For more information: www.galderma.com . References
1. Jimenez SA, Mendoza FA, Piera-Velasquez S. A review of recent studies on the pathogenesis of Systemic Sclerosis: focus on fibrosis pathways. Front Immunol . 2025;16: 1551911. doi: 10.3389/fimmu.2025.1551911
2. Truchetet ME, et al. Current Concepts on the Pathogenesis of Systemic Sclerosis. Clin Rev Allergy Immunol . 2021;64(3): 262–283. doi: 10.1007/s12016-021-08889-8
3. Teresa J, et al. Therapeutics in chronic pruritus of unknown origin. Itch . 2023;8(1): pe64. doi: 10.1097/itx.0000000000000064
4. Silverberg JI, et al. Phase 2B randomized study of nemolizumab in adults with moderate-to-severe atopic dermatitis and severe pruritus. J Allergy Clin Immunol . 2020;145(1): 173-182. doi: 10.1016/j.jaci.2019.08.013
5. Nemluvio ® U.S. Prescribing Information. Available online . Accessed June 2025
6. Nemluvio ® European Medicines Agency. Summary of Product Characteristics. Available online . Accessed June 2025
7. Andrade E, et al. Interventions for chronic pruritus of unknown origin. CDSR . 2020;1(1): CD013128. doi: 10.1002/14651858.CD013128.pub2
8. Scleroderma & Systemic Sclerosis. National Health Service. Available online . Accessed June 2025
9. Chugai Pharmaceutical Co., Ltd. Maruho Obtained Regulatory Approval for Mitchga, the first Antibody Targeting IL-31 for Itching Associated with Atopic Dermatitis. Available online . Accessed June 2025
10. Chugai Pharmaceutical Co., Ltd. Mitchga Approved for Itching in Pediatric Atopic Dermatitis and Prurigo Nodularis, for its Subcutaneous Injection 30mg Vials. Available online . Accessed June 2025
View source version on businesswire.com: https://www.businesswire.com/news/home/20250624095800/en/
CONTACT: For further information:
Christian Marcoux, M.Sc.
Chief Communications Officer
[email protected]
+41 76 315 26 50
Richard Harbinson
Corporate Communications Director
[email protected]
+41 76 210 60 62
Céline Buguet
Franchises and R&D Communications Director
[email protected]
+41 76 249 90 87
Emil Ivanov
Head of Strategy, Investor Relations, and ESG
[email protected]
+41 21 642 78 12
Jessica Cohen
Investor Relations and Strategy Director
[email protected]
+41 21 642 76 43
KEYWORD: SWITZERLAND EUROPE
INDUSTRY KEYWORD: HEALTH OTHER HEALTH CLINICAL TRIALS RESEARCH SCIENCE PHARMACEUTICAL BIOTECHNOLOGY
SOURCE: Galderma
Copyright Business Wire 2025.
PUB: 06/25/2025 01:00 AM/DISC: 06/25/2025 01:01 AM
http://www.businesswire.com/news/home/20250624095800/en
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
an hour ago
- Yahoo
Orion constellation glows red in gorgeous deep space photo
When you buy through links on our articles, Future and its syndication partners may earn a commission. Miguel Claro is a professional photographer, author and science communicator based in Lisbon, Portugal, who creates spectacular images of the night sky. As a European Southern Observatory Photo Ambassador and member of The World At Night and the official astrophotographer of the Dark Sky Alqueva Reserve, he specializes in astronomical "Skyscapes" that connect both Earth and the night sky. This deep view of the Orion Constellation glows in reddish hues thanks to a filtered view of hydrogen alpha emission, a type of light emitted by hydrogen atoms. The large, intricate semi-circle around the three stars that make up Orion's belt is known as Barnard's Loop (Sh2-276), a nebula about 1,600 light-years away that itself spans some 300 light-years across. Barnard's Loop is part of the even bigger Orion molecular cloud complex, made up of dust, hydrogen and helium, and is the birthplace of stars. I always wanted to make an image like this one that shows all the beautiful reddish hydrogen that surrounds one of the most spectacular and colorful regions of the entire night sky as seen from Earth. This cloud contains known wonders like M42, Horse Head, LDN 1622, the large Lambda Orionis Ring and the bluish (OIII) Witch Head Nebula, close to Rigel star. I had my set up for this shot (Samyang 35mm f1.8 with Poseidon C Pro) available and prepared for two months before Orion cooperated. This image was a bit challenging to capture, due to uncooperative weather and the fact that the Orion constellation was beginning to set early along the western horizon. I only had 40 minutes available for each clear night between February and March 2025 as seen from the Dark Sky Alqueva Reserve in Portugal, so collecting the seven hours of data in total for this image took many nights. Had I taken it in the beginning of winter, I could have taken it in one night. I hope you enjoy the result. I hope you enjoy it as much as I do, and if you want to support my work as an independent artist, you can buy one of my images as a print and a piece of art or a wall decor for your sweet home! Explore the size options and different types available on my Print gallery. Meanwhile, you can sign-up my newsletter to get early access of future releases.
Medscape
an hour ago
- Medscape
Age Ups Risk for Acute Dacryocystitis in Blocked Tear Ducts
TOPLINE: Acute dacryocystitis (AD) is common in women and becomes increasingly likely with age, particularly in individuals with primary acquired obstruction of the tear duct. To prevent this condition, clinicians may recommend surgery to create a new drainage pathway for tears in individuals aged 70 years or older who present symptoms such as excessive tearing or cysts filled with mucus in the eye. METHODOLOGY: Researchers conducted a retrospective observational study to determine the risk factors for AD in adults with or without primary acquired obstruction of the tear duct. They analyzed 106 patients (mean age, 64.9 years; 81% women) diagnosed with AD between January 2000 and February 2020, considering only the first attack in case of recurrent episodes; those with congenital or secondary acquired obstruction of the tear duct were excluded. AD was diagnosed when a patient suddenly developed swelling, redness, or pain in the inner corner of the eye, with or without a history of excessive tearing, an obstruction of the tear duct, or the presence of a cyst in the tear drainage system. Patients were classified as having primary acquired obstruction of the tear duct if flushing the affected side with saline (before the onset of AD or after the infection calmed) showed a blockage. Monthly averages of data on temperature, humidity, pressure, and amount of precipitation were collected from the Royal Meteorological Institute of Belgium over the entire duration of the study. TAKEAWAY: Half of the patients had a blockage in the tear duct, 20% had no blockage, and the rest could not be classified because data on flushing were missing or incomplete. The incidence of AD rose significantly with age, with the risk increasing by 15.8% for every 5-year increase in age (exponentiated coefficient [Exp{B}], 1.158; P = .008). In patients with a blockage of the tear duct, the risk rose by 22.1% for every 5-year increase in age (Exp[B], 1.221; P = .002); however, no association was observed between increased age and the risk for AD in patients with an open tear passage. The incidence of AD was not statistically linked to any changes in the abovementioned weather conditions during the 14 days prior to infection onset. IN PRACTICE: The elevated risk for AD in older women with primary acquired nasolacrimal duct obstruction suggests the threshold to perform dacryocystorhinostomy should be lower for these patients, the researchers wrote. They proposed age 70 years as when clinicians should consider preventive dacryocystorhinostomy in patients with symptoms of primary acquired nasolacrimal duct obstruction, such as epiphora or mucocele. SOURCE: This study was led by Amber Demeuleneere of the Department of Ophthalmology at the University Hospitals Leuven, Leuven, Belgium. It was published online on June 18, 2025, in British Journal of Ophthalmology. LIMITATIONS: Mostly patients with severe AD were seen at the referral center. Those with blockage of the tear duct were not followed up over time. The use of weather averages on a monthly basis may have masked the effects of shorter durations of weather phenomena. DISCLOSURES: No grant support was received for this study. No relevant conflicts of interest were disclosed. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Yahoo
an hour ago
- Yahoo
Rocket Lab to Launch Electron Mission for European Space Agency's Next-Generation Navigation System
LONG BEACH, Calif., June 25, 2025--(BUSINESS WIRE)--Rocket Lab Corporation (Nasdaq: RKLB) ("Rocket Lab" or the "Company"), a global leader in launch services and space systems, today announced it has been selected to launch a dedicated Electron mission for the European Space Agency ("ESA") for the first time, to deploy the first pair of satellites for a future navigation constellation for Europe, LEO-PNT. Rocket Lab will launch two "Pathfinder A" spacecraft for ESA, provided by European satellite prime contractors Thales Alenia Space and GMV, from Rocket Lab Launch Complex 1 no earlier than December 2025. The spacecraft will be deployed to a 510km low Earth orbit as part of a mission to test a new approach of providing location, direction, and timing services from satellites in low orbit – otherwise called LEO-PNT (Low Earth Orbit Positioning, Navigation, and Timing). ESA's LEO-PNT demonstration mission will assess how a low Earth orbit fleet of satellites can work in combination with the Galileo and EGNOS constellations in higher orbits that provide Europe's own global navigation system. Rocket Lab founder and CEO, Sir Peter Beck, says: "Launching a European mission on Electron that is integral to the future of Europe's satellite navigation system is both an honor and a testament to our industry-leading launch service. An important constellation like LEO-PNT needs a strong foundation to grow from, and with Electron's track record of precise orbital deployment, we're excited to help secure the future of LEO-PNT for Europe with our launch of these first two satellites in the constellation." This latest launch contract underscores Electron's international reputation as an industry-leading launcher, and reinforces Rocket Lab's commitment to supporting the growing demand for space access by European constellation operators. Earlier this year Electron completed the deployment of an entire constellation of Internet-of-Things satellites for French satellite operator Kinéis, before launching a global wildfire detection mission for Germany-based customer OroraTech. Missions for other European satellite operators on Electron date back to 2021. About Rocket Lab Founded in 2006, Rocket Lab is an end-to-end space company with an established track record of mission success. We deliver reliable launch services, satellite manufacture, spacecraft components, and on-orbit management solutions that make it faster, easier, and more affordable to access space. Headquartered in Long Beach, California, Rocket Lab designs and manufactures the Electron small orbital launch vehicle, the HASTE suborbital launch vehicle for hypersonic tests, a family of flight proven spacecraft, and the larger Neutron launch vehicle for constellation deployment. Since its first orbital launch in January 2018, Rocket Lab's Electron launch vehicle has become the second most frequently launched U.S. rocket annually. Rocket Lab has deployed 200+ payloads from its launch sites in the United States and New Zealand for private and public sector organizations, enabling operations in national security, scientific research, space debris mitigation, Earth observation, climate monitoring, and communications. Rocket Lab's family of spacecraft have been selected to support NASA missions to the Moon and Mars, as well as the first private commercial mission to Venus. Rocket Lab has three launch pads at two launch sites, including two launch pads at a private orbital launch site located in New Zealand and a third launch pad in Virginia. To learn more, visit Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward looking statements contained in Section 27A of the Securities Act of 1933, as amended (the "Securities Act") and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). All statements contained in this press release other than statements of historical fact, including, without limitation, statements regarding our launch and space systems operations, launch schedule and window, safe and repeatable access to space, Neutron development, operational expansion and business strategy are forward-looking statements. The words "believe," "may," "will," "estimate," "potential," "continue," "anticipate," "intend," "expect," "strategy," "future," "could," "would," "project," "plan," "target," and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including but not limited to the factors, risks and uncertainties included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, as such factors may be updated from time to time in our other filings with the Securities and Exchange Commission (the "SEC"), accessible on the SEC's website at and the Investor Relations section of our website at which could cause our actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. View source version on Contacts Rocket Lab Media Contact Murielle Bakermedia@
